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CMC Portfolio Management Lead job in Rahway

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Merck & Co. jobs
New Jersey (NJ), Rahway
Job Code:  REG003900
Employer:  Merck & Co.
Category:  Regulatory Affairs

Country:  United States
State:  New Jersey (NJ)
City:  Rahway

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Under the guidance of the Executive Director, Global Regulatory Affairs - Chemistry, Manufacturing & Controls (CMC) Program Management Office, the CMC Portfolio Management Lead will be responsible for installation of holistic CMC portfolio management capability to enable visibility of CMC regulatory activity status, risks & resource utilization to the Regulatory CMC leadership team. The CMC Portfolio Management Lead will manage a team of 5 or more staff to establish portfolio management capability, and drive synergies across portfolio tools and processes to optimize existing approaches. The CMC Portfolio Management Lead will define the approach and manage the team to implement and maintain tools such as dashboards to enable portfolio visibility for optimized CMC resource management, prioritization and risk management.

The portfolio manager will also direct or execute ad - hoc project management activities as needed for select high priority, complex projects at the request of Regulatory Affairs CMC leadership team.

The CMC Portfolio Management Lead responsibilities include but are not limited to:

• Lead the development and management of a detailed portfolio view of Regulatory CMC deliverables in conjunction with cross-functional stakeholders and output from submission management systems
• Liaise with outsourcing vendors to identify and develop opportunities for automation and creative IT solutions for CMC portfolio management (e.g. tools, dashboards)
• Collaborate with other functions in Global Regulatory Affairs including Resource Management, Business Operations, Information Management and Portfolio Management to drive for alignment and optimized communications.
• Manage the CMC Change Initiative portfolio within overall Global Regulatory Affairs portfolio management forums, proactively identifying intersections and representing an integrated view of the business
• Lead a regular cadence of portfolio status updates and escalate issues to executive CMC leadership and Global Regulatory Affairs leadership, as needed
• The incumbent may be requested to manage projects that impact business processes, organizational operations, and/or resource management capabilities to support overall Global Regulatory Affairs CMC operations.
• The candidate may be required to travel to other Merck sites on a periodic basis.

The CMC Portfolio Management Lead responsibilities also include people management responsibilities as follows:

• Manage 5 or more individual contributor CMC portfolio and project managers.
• Embody the Merck Values and Leadership Behaviors in day - to - day activities and serve as an example by practicing them consistently.
• Continuously evaluate and develop talent within the team and prepare a succession plan.
• Use recognition and rewards to promote team and organizational collaboration.
• Set a vision for the team and hold employees accountable for execution of departmental policies and procedures.
• Flexibly manage and allocate resources within area to support execution and delivery of prioritized work to meet business commitments.
• Actively sponsor employees who lead and participate in Merck initiatives.

Education Minimum Requirement:

• Bachelor's Degree, in a related discipline, with at least 10 - 15 years of experience within a healthcare / consumer care industry business / financial operations, performance management or project management

Required Experience and Skills:

• Demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
• Ability to act independently, delegate effectively to drive initiatives and other requests in a proactive, forward thinking manner.
• Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines.
• Capability to manage staff and work effectively in matrix organizational structures.
• Experience in 1 or more project management methodologies (e.g. PMP, Sigma, or Change etc.) and associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
• Minimum 3 years managing people

Preferred Experience and Skills:

• Exposure to Regulatory Affairs and/or Regulatory CMC, either through direct experience, or via a role in R&D or manufacturing
• Master's or advanced degree with at least 10 - 15 years of experience in pharmaceutical industry.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to .

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
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